FDA ALERT [11/2005]
Three patients in a clinical study of the
drug Campath for the treatment of Multiple Sclerosis (MS)
developed severe idiopathic thrombocytopenic purpura (ITP). One
of the patients died.
ITP happens when the body attacks and kills its own blood
platelets. Platelets are a type of blood cell that controls
bleeding. Bruising and bleeding may be warning signs of ITP.
Campath is not approved to treat MS. Campath is only approved
for treating a form of blood cancer called B-cell chronic
lymphocytic leukemia (B-CLL). The label for Campath has a
warning about serious and rare blood problems that may happen
with the use of this medicine.
Talk to your healthcare professional if you have concerns about
taking Campath.
This information reflects FDA’s preliminary analysis of data
concerning this drug. FDA is considering, but has not reached a
final conclusion about, this information. FDA intends to update this
sheet when additional information or analyses become available.